K241188
- 510(k) number
- K241188
- Device name
- Acucy® Influenza A&B Test with the Acucy® 2 System
- Applicant
- SEKISUI Diagnostics, LLC CA · US
- Product code
- PSZ — Devices Detecting Influenza A, B, And C Virus Antige
- Decision date
- 2025-04-18
- Date received
- 2024-04-29
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K241188.pdf
Official FDA record: K241188
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.